Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06282999 · 2 trials · 1 indication
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
| Arm | Type | Description |
|---|---|---|
| Part A Cohort 1 | EXPERIMENTAL | - |
| Part A Cohort 2 | EXPERIMENTAL | - |
| Part A Cohort 3 | EXPERIMENTAL | - |
| Part A Cohort 4 | EXPERIMENTAL | - |
| Part A Cohort 5 | EXPERIMENTAL | - |
| Part B Cohort 1 | EXPERIMENTAL | - |
| Part B Cohort 2 | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-06282999 | DRUG | Tablet, 10 mg, every 8 hours, 14 days |
| Placebo | DRUG | Tablet, 0 mg, every 8 hours, 14 days |
| midazolam | DRUG | Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14 |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...
PF-06282999 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in Phase 1 clinical trials in healthy adult volunteers, including overweight adults, but its specific therapeutic indication has not been disclosed. It is not approved for any use.
PF-06282999 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both Phase 1 trials of the compound, which were conducted in Belgium.
PF-06282999 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
PF-06282999 has been evaluated in two completed Phase 1 trials. NCT01707082 tested its safety, pharmacokinetics, and effects on midazolam in healthy overweight and healthy adults, enrolling 69 participants. NCT01626976 assessed its safety, tolerability, and pharmacokinetics in 42 healthy adults. Both trials were conducted in Belgium.
Both Phase 1 trials of PF-06282999 were randomized, double-blind, and controlled studies in healthy adult volunteers. NCT01707082 enrolled 69 participants, including healthy overweight adults, and NCT01626976 enrolled 42 healthy adults. Together they included 111 participants, and both trials have been completed.